Taiwan FDA registration ee54adeaf472b5a9081b6bd3c8744c57

Quantum blue calprotectin amplification range test set

TW: 量子藍鈣衛蛋白擴增量測範圍檢驗試劑組

Taiwan·Risk Class 2·BÜHLMANN LABORATORIES AG·Registered May 05, 2022 – May 05, 2027Active

Registration details

Analysis ID: ee54adeaf472b5a9081b6bd3c8744c57
Customs Code: DHA05603524401

Company information

Manufacturer: BÜHLMANN LABORATORIES AG
Manufacturer Country: Switzerland
Authorized Representative: Siloam Biotech Co., Ltd.

Product details

Intended Use: This product is an in vitro diagnostic test for the quantitative determination of calprotectin in human stool samples to help assess inflammation of the intestinal mucosa.
Product Type (Level 1): A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
Product Type (Level 2): C.5180 Fecal Calcium Protein Immunoassay System;; A.1660 Quality control materials (analytical and non-analytical)
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: May 05, 2022
Expiry Date: May 05, 2027

About this record

Access comprehensive regulatory information for Quantum blue calprotectin amplification range test set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ee54adeaf472b5a9081b6bd3c8744c57 and manufactured by BÜHLMANN LABORATORIES AG. The authorized representative in Taiwan is Siloam Biotech Co., Ltd..

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